# FDA recall Z-0575-2020

> **Abbott GmBH & Co. KG** · Class II · device recall initiated 2019-10-23.

## Product

Alinity c Carbon Dioxide Reagent Kit,  Produced for Abbott by Sekisui Diagnostics P.E.I. Inc. Prince Edward Island Canada

## Reason for recall

Abbott internal studies have determined that atmospheric Carbon Dioxide (CO2) can be absorbed into the Alinity c Carbon Dioxide reagent, resulting in the potential for incorrect results. Abbott was made aware of this issue from customer complaints. Internal testing demonstrated that the amount of CO2 absorbed is higher with increased reagent carousel rotation and when the volume of reagent in the cartridge is reduced. This phenomenon can be detected as a shift in QC. The shift is predictive in both direction and magnitude of the potential impact to patient results.

## Distribution

Worldwide and US Nationwide in the states of:  AL, AR, CA, CO, FL, GA, ID, IL, LA, MA, MI, MN, MO, NC, NY, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and Puerto Rico   Foreign: AUSTRALIA, BANGLADESH, BELGIUM, BOTSWANA, BRAZIL, CANADA, COLOMBIA, DENMARK, FRANCE, GREECE, Hong Kong,   INDIA, ITALY, JAMAICA, LEBANON, MAURITIUS, NAMIBIA, NETHERLANDS, NEW ZEALAND, PAKISTAN, PHILIPPINES, POLAND, PORTUGAL,  PORTUGAL, ROMANIA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD & TOBAGO,   UAE, and UNITED KINGDOM

## Key facts

- **Recall number:** Z-0575-2020
- **Recalling firm:** Abbott GmBH & Co. KG
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-10-23
- **Report date:** 2019-12-04
- **Termination date:** 2021-05-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wiesbaden, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0575-2020

## Citation

> AI Analytics. FDA recall Z-0575-2020. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/Z-0575-2020. Source: US FDA. Licensed CC0.

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